1. Medicines regulation - ensuring effective medicines with acceptable risk

Excessive promotion of pharmaceuticals has been associated in many countries with serious problems of irrational drug use. Unethical medicines promotion activities often convey misleading information about medicines to the different target audiences. Misinformation can contain expansion of indications or an exaggeration of efficacy but can also downplay the seriousness or the incidence of side effects. In the EU, the directive 2001/83/EC contains relevant provisions regarding advertising for medicinal products which are reflected in the legislation of the EU member states. For example, advertising of a medicinal product, for which a marketing authorization has not been granted, is prohibited; only product information approved during the authorisation process can be included in the package leaflets or promotional materials; direct to the general public advertising of prescription only medicines is not allowed; the advertising of a medicinal product to the general public shall not contain any statements which are in any way misleading, such as that the effects of taking the medicine are guaranteed, are unaccompanied by adverse reactions or are better than those of another treatment or medicinal product (a more extensive list can be found in the directive (Article 90)).